Topics. ICH Prague Meeting Held
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) held its second half of 2023 in Prague, Czech Republic, from October 28 to November 1. Although face-to-face meetings were again the rule for participation in the meeting, web conferencing continued to operate as before in case of unavoidable travel or health issues.
Overall picture
At this meeting, the Management Committee, which is responsible for the preparation of proposals to be discussed at the Assembly and for the management of the ICH, and the Assembly, in which all members participate, were held. In addition, the 16 expert working groups that are considering technical guidelines also held discussions in parallel during the same period to make progress in developing the ICH guidelines.
Participating organizations at the Prague meeting included six industry-government organizations*1 from Japan, the U.S., and the EU, which are founding members; two Standing Members (Health Canada and Swissmedic); 13 Members*2; two Standing Observers*3; and 21 Observers. More than 500 participants from around the world attended the meeting in Prague, and 35 JPMA members, including experts from the Expert Working Group, participated in the meeting on-site.
The following is a list of special notes based on the ICH Management Committee and ICH Assembly in Prague.
- 1U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers Association of America (PhRMA), European Federation of Pharmaceutical Manufacturers and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA)
- 2Brazilian National Health Regulatory Agency (ANVISA), Korea Food and Drug Safety Administration (MFDS), National Medical Products Administration (NMPA) of China, Singapore Health Sciences Authority (HSA), Taiwan Food and Drug Administration (TFDA), Turkish Medical Products Regulatory Agency (TITCK), Saudi Arabia Food and Drug Administration (TFDA), COFEPRIS (Federal Commission for Protection against Sanitary Risks) Mexico, MHRA (UK), Egyptian Drug Authority (EDA), BIO (Biotechnology Innovation Organization), IGBA (International Generic and Biosimilar Medicines Association), GSCF (Global Self-Care Federation)
- 3World Health Organization (WHO), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
1. new members and observers
No new organizations applied to become ICH members. However, the Pharmacy and Poisons Board of Hong Kong, PPBHK, applied to join ICH as a new ICH observer, which was approved at the ICH Assembly.
As a result, ICH now has 21 member organizations and 37 observer organizations, bringing the total number of ICH members to 58 (see reference material at the end of this report).
2. Trends in ICH Technical Topics
At the Prague meeting, working groups on a total of 16 topics held active discussions and made progress.
Working groups that met
| • | Q1/Q5C EWG: Revision of Stability Testing Guidelines for Drugs |
| • | Q2 (R2)/Q14 EWG: Revision of "Validation of Analytical Procedure" and "Analytical Procedure Development" |
| • | Q3E EWG: Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products |
| • | Q5A (R2) EWG: Revision of "Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin" |
| • | Q9(R1) IWG: "Guidelines for Quality Risk Management" Q9(R1): "Quality Risk Management |
| • | E2B (R3) EWG/IWG: Revision of "Data Elements and Transmission of Individual Case Safety Report (ICSR)" |
| • | E6 (R3) EWG: Revision of "Good Clinical Practice" |
| • | E11A EWG: Pediatric Extrapolation |
| • | E20 EWG: Adaptive Clinical Trials |
| • | E21 informal WG: Inclusion of pregnant and breastfeeding individuals in clinical trials |
| • | M1PtC WG: ICH International Glossary of Pharmaceutical Terms (MedDRA) |
| • | M4Q(R2)EWG: Revision of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality |
| • | M11 EWG: Clinical electronic Structured Harmonised Protocol (CeSHarP) |
| • | M12 EWG: Drug Interaction Studies |
| • | M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
| • | M15 EWG: General Principles for Model-Informed Drug Development |
At the Prague meeting, the ICH Assembly approved Q2(R2) "Guidelines for Validation of Analytical Methods", Q14 "Guidelines for Development of Analytical Methods", and Q5A(R2) "Guidelines for Viral Safety Assessment of Biotechnology-based Pharmaceuticals Manufactured from Human or Animal Cell Lines", (Reaching Step 4 means that the final English version of the guideline has been finalized and is now in the process of being implemented by regulatory authorities.)
3. ICH Awards
The ICH Award was established in 2022 to recognize experts who have demonstrated leadership and made significant contributions to the development of the ICH Guidelines. From Japan, one was selected from the regulatory side and one from the industry side. From the industry side, Mr. Shigeru Hisada, JPMA's safety domain expert (formerly of the Drug Evaluation Committee), received the award in recognition of his important leadership and sustained contributions to ICH's expert working groups. 4.
4. election of Chair and Vice-Chair of ICH Assembly/Management Committee
With the expiration of the terms of office of the Chair and Vice-Chair of the ICH Assembly and Management Committee, elections were held at the Prague meeting. As a result of the election, Mr. Naoyuki Yasuda, Executive Officer of PMDA, was re-elected as Vice Chair of the ICH Management Committee.
| ICH Assembly: | Chair Ms. Lenita Lindström (EC) Vice-Chair Ms. Gabriela Zenhaeusern (Swissmedic) |
| ICH Management Committee: | Chair Ms. Theresa Mullin (FDA) Vice Chair Mr. Naoyuki Yasuda (MHLW/PMDA) |
5. Next ICH Meeting
The meeting is scheduled to be held in Fukuoka, Japan from June 1 to 5, 2024.
ICH actively discloses information on ICH activities, including the outcomes of ICH meetings, to deepen understanding of ICH activities among the public as well as relevant parties. The results of the ICH Prague meeting, concept papers on each topic, work plans, etc. are available on the ICH website ( https://www.ich.org/ ).
[Reference: List of ICH Members and Observers (as of November 2023)
Table 1 Members (21 organizations)
Table 2 Observers (37 organizations)
Shaded areas were added at the ICH Prague meeting.
( Mariko Kato, Director, International Regulatory Coordination Department)